Irbesartan Hydrochlorothiazide BMS

Irbesartan Hydrochlorothiazide BMS can be taken once daily, with or without food. e. irbesartan and hydrochlorothiazide) may be recommended. 5 mg. 5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.

5). Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this population.

Medicinal product no longer authorised 3 Hepatic impairment:

Irbesartan Hydrochlorothiazide BMS is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function. 3). Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients.

Paediatric patients:

Irbesartan Hydrochlorothiazide BMS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

25 mg to 300 mg/25 mg irbesartan/hydrochlorothiazide). The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Uncommon: swelling extremityMusculoskeletal and connective tissue disorders: Not known: arthralgia, myalgia Metabolism and nutrition disorders: Not known: hyperkalaemia Vascular disorders: Uncommon: flushing General disorders and administration site conditions: Common: fatigue Immune system disorders: Not known: cases of hypersensitivity reactions such as angioedema, rash, urticaria Hepatobiliary disorders: Not known: hepatitis, abnormal liver function Reproductive system and breast disorders: Uncommon: sexual dysfunction, libido changes * Frequency for adverse reactions detected by spontaneous reports is described as “not known” Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan Hydrochlorothiazide BMS.

Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan Hydrochlorothiazide BMS. 4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides Cardiac disorders: Not known: cardiac arrhythmias Blood and lymphatic system disorders: Not known: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia Nervous system disorders: Not known: vertigo, paraesthesia, light-headedness, restlessness Eye disorders: Not known: transient blurred vision, xanthopsia Respiratory, thoracic and mediastinal disorders: Not known: respiratory distress (including pneumonitis and pulmonary oedema) Gastrointestinal disorders: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite Renal and urinary disorders: Not known: interstitial nephritis, renal dysfunctionMedicinal product no longer authorised 9 Skin and subcutaneous tissue disorders: Not known: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria Musculoskeletal and connective tissue disorders: Not known: weakness, muscle spasm Vascular disorders: Not known: postural hypotension General disorders and administration site conditions: Not known: fever Hepatobiliary disorders: Not known: jaundice (intrahepatic cholestatic jaundice) Psychiatric disorders: Not known: depression, sleep disturbances The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.

Hypotension - Volume-depleted patients:

Irbesartan Hydrochlorothiazide BMS has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.

Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide BMS. Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.

While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated. Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide BMS is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.

There is no experience regarding the administration of Irbesartan Hydrochlorothiazide BMS in patients with a recent kidney transplantation. 3). Thiazide diuretic-associated azotemia may occur in patients with impaired renal function.

No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min. However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.

Hepatic impairment: thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. There is no clinical experience with Irbesartan Hydrochlorothiazide BMS in patients with hepatic impairment.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.

Medicinal product no longer authorised 4 Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during thiazide therapy.

5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported. Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.

Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis). Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting.

Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia. The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.

Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide BMS hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus. Adequate monitoring of serum potassium in patients at risk is recommended.

5). There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia. Chloride deficit is generally mild and usually does not require treatment. Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.

Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia.

5). Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotemia, oliguria, or rarely acute renal […]

6) ƒ Severe renal impairment (creatinine clearance < 30 ml/min) ƒ Refractory hypokalaemia, hypercalcaemia ƒ Severe hepatic impairment, biliary cirrhosis and cholestasis